A Study of KRN23 in Subjects With X-linked Hypophosphatemic Rickets/Osteomalacia

• Sponsor: Kyowa Kirin Co., Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02181764
• Collaborator: (none)
• Enrollment: 15
• Locations: 2
• Arm: 1
• Actual Duration (Months): 11
• Patients Per Site: 7.5
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

The objective of this study is to assess the safety and tolerability of KRN23 after a single subcutaneous (SC) administration in subjects with X-linked hypophosphatemic rickets/osteomalacia (XLH) in Japan or Korea.

Condition or Disease	Intervention/Treatment	Phase
X-linked Hypophosphatemic Rickets/Osteomalacia	Drug: KRN23	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 15 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 1, Multicenter, Open-label, Sequential Dose-escalation, Single-dose Study to Assess the Safety and Tolerability of KRN23 in Subjects With X-linked Hypophosphatemic Rickets/Osteomalacia.
• Actual Study Start Date: Jul 1, 2014
• Actual Primary Completion Date: Jun 1, 2015
• Actual Study Completion Date: Jun 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: KRN23 Single SC administration on day 1	Drug: KRN23; Single SC administration on day 1: 0.3, 0.6 and 1.0 mg/kg

Outcome Measures

Primary Outcome Measures

1. Number and types of adverse events [Up to 7 weeks after dosing]

   The safety of KRN23 assessed by number and types of adverse events, laboratory tests

Secondary Outcome Measures

1. Profiles of pharmacokinetics [Pre-dose, 24, 48, 96, 168, 336, 504, 672, 840, 1176 hours post-dose]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. 18 years or older

2. Patients with XLH

Exclusion Criteria:

1. Have an active infection or chronic inflammatory disease

2. Have uncontrolled hypertension

3. Have uncontrolled diabetes mellitus

4. History of known immunodeficiency

5. Use of a pharmacologic vitamin D metabolite or its analogs within 21 days prior to screening and after screening

6. Use of phosphate, calcium preparation, calcimimetics, aluminum hydroxide antacids, thiazide diuretic, acetazolamide, or phosphate, calcium, and/or vitamin D-containing supplements within 10 days prior to screening and after screening

7. Pregnant or lactating females, women who are possibly pregnant or patients who have no intention of utilizing adequate contraception

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Tokyo		Japan
2		Seoul		Korea, Republic of

Sponsors and Collaborators

• Kyowa Kirin Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kyowa Kirin Co., Ltd.
• ClinicalTrials.gov Identifier: NCT02181764
• Other Study ID Numbers: KRN23-001
• First Posted: Jul 4, 2014
• Last Update Posted: Mar 3, 2017
• Last Verified: Feb 1, 2017

• Keywords provided by Kyowa Kirin Co., Ltd.: XLH
• Additional relevant MeSH terms: Rickets; Osteomalacia; Rickets, Hypophosphatemic; Familial Hypophosphatemic Rickets

Study Results

No Results Posted as of Mar 3, 2017